FDA Releases Customer List of Pharmacy Tied to Meningitis Outbreak

List includes nine facilities in Dallas-Fort Worth area, but FDA says list contains incorrect data

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    AP
    This photo provided Oct. 9, 2012, by the Minnesota Department of Health shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak.

    The federal government has released a customer list for the specialty pharmacy at the center of a national fungal meningitis outbreak.

    The Food and Drug Administration on Monday listed the medical practices in each state that got any products since May that were later recalled and how much each received.

    Nearly 1,300 facilities across the country recently received drugs from the New England Compounding Center, of Framingham, Mass.

    The list includes 63 places in Texas, including doctors, hospitals and surgery centers.

    Nine are in the Dallas-Fort Worth area, including five in Dallas and one each in Fort Worth, Plano, Mansfield and Corsicana.

    However, the FDA later posted a note saying that it had found some technical problems with the list and that the data was incorrect. The agency said it was working to correct the list and would repost it when it was sure it was accurate.

    A Baylor Medical Center at Dallas spokeswoman told NBC 5 that it had checked its pharmacy records Monday afternoon against the voluntary recall list and found that it did not order any of the drugs on the list.

    Last month, the company recalled the steroid shots that went to clinics in 23 states. That recall was later expanded to all its products, and the lists show they went to a longer list of states.

    The FDA is advising the medical practices to stop using any of the drugs from the New England Compounding Center and reach out to patients who received any injectable product supplied by the company since May 21.

    People who got injections near the spine are the ones most at risk. Patients should call their doctor if they're concerned.

    The symptoms of meningitis include fever, headache, stiff neck, nausea and sensitivity to light.

    The outbreak of meningitis, an inflammation of the lining of the brain and spinal cord, has sickened nearly 300 people, including 23 who died, in more than a dozen states. At least one woman in North Texas has developed meningitis from the shots.

    Each victim had received a steroid shot, mostly for back pain. Federal health officials matched the shots produced by the company to the outbreak after finding a deadly fungus in more than 50 unopened vials there but have not said how the shots were contaminated.

     

    A congressional committee on Monday sought a decade's worth of records from the company at the center of the outbreak as new state documents detailed problems an outside firm hired to do an assessment found there in 2006.

     

    The state documents, obtained by The Associated Press under a public records request, say investigators in 2006 found inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the New England Compounding Center. The problems were corrected that year, and a state inspection in May 2011 as the company prepared to update its facilities found no such issues.

    In a letter sent Monday to a lawyer for NECC, the House Committee on Energy and Commerce seeks nearly 10 years of documents about safety and quality issues at the company. It indicates that as far back as 2002 and 2003, officials from the FDA and the state conducted joint probes of the company after receiving a report about a steroid shot. Those probes preceded a 2004 joint investigation of the center by the FDA and the Massachusetts Board of Registration in Pharmacy.

    In January 2006, based on several complaints, the company signed with state regulators a consent agreement in which it agreed to a full inspection of its drug compounding practices by investigators.

    The company's encounters with regulators have been reported since the outbreak began, but state pharmacy board documents released Monday offer a new level of detail. They show the inspection by Illinois-based Pharmaceutical Systems Inc. found "significant gaps" in procedures and a lack of required documentation at the NECC facility in Framingham, just west of Boston.

    More: Fungal Meningitis Outbreak Updates at FDA's website